Alendronate Prevents Hip and Other Fractures According to Study
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Alendronate Prevents Hip and Other Fractures According to Study

AMSTERDAM, The Netherlands, May 22, 1996 -- Post-menopausal women with osteoporosis who have had a previous spinal fracture and who take the medicine alendronate are at 51% lower risk of debilitating hip fractures and 46% lower risk of new spinal fractures, according to UCSF researchers who reported major study findings during an international osteoporosis conference.

Other Key findings reported include:

- 89% reduction in multiple (two or more) spinal fractures

- 57% reduction in painful spinal fractures

- 44% reduction in wrist fractures

- 50% reduction in loss of height

"This is the first study to show a reduction in hip fractures in a general population of post-menopausal women with osteoporosis," says Dennis Black, PhD, UCSF associate professor of epidemiology and biostatistics, who presented the initial findings of the largest osteoporosis study ever conducted during the World Congress on Osteoporosis in Amsterdam.

"The results are exciting and significant, because nearly all hip fractures require hospitalization," Black says, "and up to 20% of women who suffer hip fractures die within a year."

Hip fractures are the most costly fractures. In the United States, for example, the annual cost of hip fractures is estimated at $10 billion.

The findings are from the first arm of the landmark Fracture Intervention Trial (FIT), a UCSF-coordinated study that includes 6,459 women at 11 academic sites across the United States. The first arm of FIT is known as the Vertebral Fracture Study, in which 2,027 women ages 55 to 80 with previous spinal fractures were enrolled.

"The majority of women enrolled in the first arm were not aware that they had suffered a spinal fracture," Black says.

An independent panel of experts that monitored the study data made the decision to halt the three-year Vertebral Fracture Study last October because they felt the results were so positive that it would be unethical to keep treating some women with a placebo, Black says. The study had been scheduled to run through June 1996

Black also reported that there were no differences in side effects in each group of women. There were 1,022 women in the alendronate group and 1,005 women in the placebo group.

"The study was extremely large, well-controlled and very rigorous," says Steven R. Cummings, MD, UCSF professor of medicine and epidemiology and biostatistics, the principal investigator of FIT and the chair of the FIT Steering Committee, which includes representatives from the 11 academic centers that took part in the study and the UCSF coordinating center.

More than 200 million women worldwide suffer from osteoporosis, according to some experts. About 250,000 Americans each year have hip fractures as result of the disease -- which causes the bones to become thin, fragile and vulnerable to fractures. Hip fractures are debilitating, almost always require hospitalization, and sometimes lead to death.

The disease is more common in women than in men, in whites than in other racial groups, and in older than in middle-aged individuals.

The second arm of FIT -- the Clinical Fracture Study -- is ongoing and will be completed in early 1997. That arm is designed to study the effect of alendronate in 4,432 post-menopausal women with osteoporosis who had not suffered a spinal fracture before entering the study.

The World Congress on Osteoporosis is a major international, scientific conference organized by the European Foundation for Osteoporosis and Bone Disease in cooperation with the National Osteoporosis Foundation (USA).

UCSF is an internationally recognized health sciences campus, research institution and medical center. The professional schools and medical center consistently rank among the best in the United States, and UCSF is in the top 10 in federal funding for biomedical research.

Alendronate, which is available as FOSAMAX in more than 30 countries including the United States, was developed by Merck & Co. Inc., USA (Merck Sharp & Dohme).

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